BTRA643 Practical Applications of Biotech Regulatory
BTRA 643 UMGC Practical Applications of Biotech Regulatory Affairs Discussion
1) Design the framework for a regulatory submission: Based on a hypothetical product, students will provide a case study of either 1) submitting non-clinical data for support of an application for a clinical trial, 2) designing and submitting label and promotional materials based on hypothetically available testing, or 3) reviewing and submitting risk assessment documentation for a product dossier.
2) Provide an example of one product and the FDA division responsible for overseeing the product.
3) What do you think about the EMA’s process for pediatric products and the fact that they now have a specific committee to render opinions on treatments for people under 18?
4) What do you think about the mutual-recognition procedure for marketing approval? How is it better/worse than the EMA’s centralized procedure? Do you see it as a ‘back door’ to approval in all member states or just a more lengthy process?
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